510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923233Unknown

Cardio-Pak Laparotomy Pack

Cardio-Med-Associates, Inc., Billings MT / Traditional, Unknown
FDA source (opens on fda.gov)

K923233 is the FDA 510(k) clearance record for CARDIO-PAK LAPAROTOMY PACK, a class II device, cleared for Cardio-Med-Associates, Inc. on under FDA product code FZH (Apparatus, Air Handling, Room). FDA records list 2 510(k) clearances for Cardio-Med-Associates, Inc., from to . As of , FDA records show one recall naming K923233.

Clearance record

Decision date
Received
(262 days to decision)
Product code
FZH Apparatus, Air Handling, Room
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cardio-Med-Associates, Inc. 1602 4th Ave. N., Billings MT
510(k) summary
Summary
Third party review
No

Clearances, product code FZH

Trailing 12 months

FDA records hold no clearances under product code FZH in the trailing twelve months.

FDA records show no clearances under product code FZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260